Fresenius Medical Care Holdings, Inc.: Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis Machines with Part Num

Hazard

Machines equipped with BPM3 Blood Pressure Modules (Blood pressure monitor TM-2917B with firmware version S005) will not record Blood Pressure measurements and does not alarm if the cuff tubing is kinked close to the cuff.

Details from the source

Reason for recall: Machines equipped with BPM3 Blood Pressure Modules (Blood pressure monitor TM-2917B with firmware version S005) will not record Blood Pressure measurements and does not alarm if the cuff tubing is kinked close to the cuff. Distribution: US Nationwide. Canada. Quantity: 3,718 systems Lot/code info: UDI-DI: 190573 NA 190713 00840861100897 (+ Serial Number) 190766 00840861100910 (+ Serial Number) 190858 00840861100903 (+ Serial Number) 190895 00840861100927 (+ Serial Number) 190908 00840861100934 (+ Serial Number) 191124 00840861102082 (+ Serial Number) 191126 00840861102099 (+ Serial Number) 191128 00840861102105 (+ Serial Number) 191130 00840861102112 (+ Serial Number) Serial Numbers: 4T0S278166 4T0S278222 4T0S278232 4T0S278242 4T0S278353 4T0S278386 4T0S278395 4T0S278427 4T0S278445 4T0S278466 4T0S278471 4T0S278474 4T0S278477 4T0S278810 4T0S278824 4T0S278832 4T0S278835 4T0S278840 4T0S278841 4T0S278842 4T0S278845 4T0S278846 4T0S278847 4T0S278848 4T0S278851 4T0S278852 4T0S278859 4T0S278860 4T0S278862 4T0S275623 4T0S275627 4T0S275628 4T0S275629 4T0S275639 4T0S275649 4T0S275654 4T0S275662 4T0S275664 4T0S275666 4T0S275677 4T0S275682 4T0S275685 4T0S275688 4T0S275692 4T0S275703 4T0S275729 4T0S275738 4T0S275742 4T0S275745 4T0S275760 4T0S275768 4T0S275769 4T0S275778 4T0S275787 4T0S275800 4T0S275804 4T0S276804 4T0S276814 4T0S276818 4T0S276829 4T0S276833 4T0S276838 4T0S276858 4T0S276867 4T0S276870 4T0S276807 4T0S276886 4T0S276894 4T0S276895 4T0S276897 4T0S276909 4T0S276911 4T0S276912 4T0S276916 4T0S276921 4T0S276926 4T0S276928 4T0S276934 4T0S276952 4T0S276960 4T0S276961 4T0S276963 4T0S276964 4T0S276965 4T0S276969 4T0S276973 4T0S276976 4T0S276979 4T0S276991 4T0S276998 4T0S276999 4T0S277004 4T0S277005 4T0S278031 4T0S278068 4T0S278087 4T0S278088 4T0S278105 4T0S278107 4T0S278109 4T0S27

UPC codes

00840861100897, 00840861100910, 00840861100903, 00840861100927, 00840861100934, 00840861102082, 00840861102099, 00840861102105, 00840861102112

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.